1. Field of the Invention
The present invention generally relates to an artificial means of supporting the bladder, the rectum, the bowel, the vagina, the urethra, and/or the uterus, more specifically, the present invention relates to a device for treating urinary incontinence, cystoceles, rectoceles, urinary prolapse, and enteroceles.
2. Background Art
Continence, or normal control of urine retention in the bladder, involves the coordination of the bladder, bladder neck and urinary sphincter. The body stores urine in the bladder by maintaining a closed bladder neck and a contracted urinary sphincter muscle. To pass urine the bladder contracts while the bladder neck opens and the urinary sphincter muscle relaxes.
Urinary incontinence (UI) occurs when one or more of the anatomical structures related to urine storage malfunctions and leads to a loss of control of urination. The most common type of incontinence is caused by hypermobility of the bladder neck and urethra due to weakening of the tissues surrounding these structures. In females, pelvic trauma associated with child birth is a common cause of tissue weakening. Another cause of incontinence is a deficiency in urinary sphincter muscle control, intrinsic sphincter deficiency (ISD). It is estimated that approximately 8.5 million women suffer from UI in the United States. Up to 75% of female nursing home patients experience some degree of urinary incontinence, creating a tremendous economic as well as hygienic burden.
Female incontinence is currently treated using behavioral techniques, various devices, surgical techniques, and pharmaceuticals. Among devices widely used for alleviating the above problem, a device, which is known as pessary, is a useful alternative or an adjunctive aid rather than a substitute for gynecological surgery. A pessary is a device, which is inserted into the vagina for controlling uterine prolapse, uterine retrodisplacement, or stress urinary incontinence via contact with the walls of the vagina.
Pelvic organ prolapse is a condition defined by herniation of pelvic organs such as the bladder, rectum, or uterus into the vagina or beyond the vaginal opening. It may also lead to complete eversion of the vagina. Pelvic organ prolapse may be caused by vaginal childbirth, hysterectomy, aging and obesity. Over 70 percent of women will eventually have some degree of pelvic organ prolapse. Symptoms may include profound discomfort, bleeding from protrusion of organs, difficulty and or inability to urinate or defecate, frequency of urination, and urinary incontinence. Pelvic organ prolapse is currently treated only by surgery or with a pessary.
Many vaginal pessary devices are known and are available within the marketplace. Some pessaries are made in the form of rigid (i.e. non-inflatable) rings, dishes, hodges, donuts, and the like. Many of such exemplary devices are produced by Millex Products, Inc., of Chicago, Ill. The aforementioned pessaries are inserted and removed manually, which often presents a problem when insertion and removal is to be performed by the patient. Often the difficulty of insertion and/or removal necessitates insertion or removal by a physician or nurse. Such professionals often also have difficulty with this and significant patient discomfort results. In the past, doctors and nurses would fit the patient with a type of pessary, insert it into the patient's vagina where it could remain for up to three months. In order to decrease vaginal infection and odor, daily, weekly or semiweekly removal and cleaning is preferred. However, secondary to the difficulty with self-removal and reinsertion and the inconvenience of making semimonthly trips to the doctor's office, it has become the convention to allow three months without removal. The patient then returns to the doctor's office where the pessary is removed, cleaned and re-inserted (or a new pessary may be substituted). Secondary to the fact that this practice results in significant vaginal discharge, odor and infection, pessaries are seldom used to treat incontinence and pelvic organ prolapse. The majority of patients instead are triaged to surgery.
The new prior art approach is to use the pessary on a daily basis by having the patient manually insert the pessary in the morning and then manually remove the pessary in the evening. When removed, the patient may clean the pessary with special solution and have the pessary ready for manual re-insertion by the patient the next morning. This is the same idea as intermittent catheterization that is now done three-four times per day by the patient rather than having an indwelling Foley catheter in the bladder for usually four weeks where only the doctor inserts and removes the catheter.
The problem with this new method of daily insertion and removal is that the patient is required to learn how to insert and remove the pessary herself. However, as has been mentioned above, the aforementioned rigid pessaries are difficult to insert and likewise, very difficult to remove by the patient alone. There is great variability in the size of the bony pelvis and the surrounding soft tissue between respective patients. To accommodate these rigid pessaries are made in a variety of different sizes, and a pessary cannot be worn if it is improperly sized. If the pessary is too big, it will cause ulceration and discomfort; however, if the pessary is too small, it may fall out or fail to provide the required support. Conventional pessaries are made available in standard sizes. Unfortunately, it has been found that a large number of women fall in the range between these conventionally available pessary sizes and are thereby unable to receive a proper size and fit.
Prior attempts have been made to make an inflatable pessary to correct this problem. Although there are several available inflatable pessaries, they are all plagued by at least two major problems. First, unlike semi-rigid pessaries which may have open channels to allow air flow, inflated pessaries have failed to maintain an open channel to provide air flow. Such a lack of air flow results in copious and malodorous vaginal discharge. Second, existing inflatable pessaries are difficult to inflate and are even more difficult to deflate. Given these inflation and deflation hardships, patients experience great difficulty in removing the pessary prior to cleaning or intercourse and pessary re-insertion thereafter.
As one example, a conventional pessary consists of a donut-type inflatable ring which is manually inserted into the vagina and which is connected via a flexible tube with an externally located pumping bulb. The inflatable donut is individually fitted and adjusted into a required place of the vagina and then is inflated to a proper size by means of the pumping bulb via the flexible tube. The donut is provided with a check valve for maintaining the pessary in an inflated state. Upon completion of inflation, the bulb is disconnected leaving a short piece of the flexible tube protruding out from the vagina, so that this protruding end can then be used for removing the donut pessary from the vagina. Such a device is produced by Millex Products, Inc., of Chicago, Ill. A disadvantage of this device is that it is still manually inserted and that the end of the flexible tube protruding from the vagina creates discomfort and serves as a wick for infection and drainage. An additional disadvantage exists in that the pessary in its inflated state allows no means of ingress and egress of air. This leads to profound and copious vaginal discharge and infection.
U.S. Pat. No. 5,611,768 issued in 1997 to R. Tutrone discloses a pessary device comprising two sequentially arranged inflatable chambers, one of which is placed into the anterior part of the vaginal cavity and another to the posterior part of the vaginal cavity. Both chambers are inflated separately via separate valves located outside the vagina and remaining attached to the device after the inflation. At least one of the chambers is intended for pressing via the vaginal wall on the urethra, thus combating female incontinence.
This device entails the same disadvantages as the previously described pessaries, in that the pessary removal means remains permanently attached to the pessary while in use. Additional disadvantages include the complicated construction of the device, the device's requirement for manual insertion and removal, the lack of a means of ingress and egress of air to decrease vaginal discharge and infection, and the lack of any semirigid or rigid component to provide increased support and resistance to unwanted movement within the vaginal cavity.
The present invention is intended to address these problems associated with the non-surgical treatment of urinary incontinence as well as treatments involving disorders such as pelvic organ prolapse. Pelvic organ prolapse refers to the herniation of the bladder, rectum, bowel, urethra, and/or uterus. This is caused by loss of support from surrounding connective tissue and muscle. Pelvic organ prolapse causes numerous symptoms such as urinary incontinence, obstruction of urination, obstruction of defecation, constipation, pain, bleeding, and problems with intercourse. It is recognized that most women will eventually develop pelvic organ prolapse, and it has been estimated that as many as 7% of these women will undergo surgery for pelvic prolapse. The problems associated with conventional pessaries have resulted in many health care providers electing for surgery without even first attempting treatment with a pessary. Of the women that are treated with a pessary, a significant portion elect surgery rather than dealing with the problems of a pessary including poor fit, pain during removal and insertion (often having to be routinely done by a healthcare provider), and the vaginal discharge that builds up behind the pessary.
The majority of patients that are successfully fit with a pessary are wearing a semi-rigid pessary. Until now, the semi-rigid pessaries have been the best available, but these devices also have significant drawbacks. Patients and physicians often have trouble inserting and removing these semi-rigid pessaries. As a result, sexual intercourse may then be abandoned and the patient may be forced to visit the physician every two to three months to have the pessary removed and cleaned by the healthcare provider. Removal is often quite painful for the patient and may even cause bleeding.
The balance that a pessary requires and which the prior art fails to achieve is a pessary which is small enough to be inserted and removed comfortably, large enough to stay in place during activity, rigid enough to allow air tunnels to remain open, and soft enough to not cause trauma or discomfort during use. Such a device is provided for by the present invention.